U.S. patent number 4,808,157 [Application Number 07/072,428] was granted by the patent office on 1989-02-28 for multi-lumen epidural-spinal needle.
This patent grant is currently assigned to Neuro Delivery Technology, Inc.. Invention is credited to Dennis W. Coombs.
United States Patent |
4,808,157 |
Coombs |
February 28, 1989 |
Multi-lumen epidural-spinal needle
Abstract
The needle of the present invention is a multi-lumen needle and
preferably a dual-lumen epidural-spinal needle. The needle of the
present invention is provided with a hub, which allows for
attachment of a syringe to one or more of the lumina, or
alternatively the attachment of an adapter to which a syringe can
be attached. Preferably the lumina have different cross sectional
areas. The smaller of the lumina should be of sufficient size to
allow a spinal neelde, guide wire, or micro-catheter to be inserted
through the lumen. The larger of the two lumina should preferably
be of sufficient size to allow an epidural catheter, spinal needle
or guide wire to be introduced. The needle of the present invention
has applications of regional anesthesia, chronic and post operative
pain management, cricothyroid puncture, intracerebroventricular
puncture and, access and drainage of concealed fluid collections
within the body.
Inventors: |
Coombs; Dennis W. (Etna,
NH) |
Assignee: |
Neuro Delivery Technology, Inc.
(Tempe, AZ)
|
Family
ID: |
22107484 |
Appl.
No.: |
07/072,428 |
Filed: |
July 13, 1987 |
Current U.S.
Class: |
604/44; 604/512;
604/272; 604/158 |
Current CPC
Class: |
A61B
17/3401 (20130101); A61B 2017/3445 (20130101); A61B
2017/22072 (20130101) |
Current International
Class: |
A61B
17/34 (20060101); A61B 17/22 (20060101); A61M
005/32 () |
Field of
Search: |
;604/43-44,51-53,158-169,272-274 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
|
|
|
|
|
|
834211 |
|
Sep 1976 |
|
BE |
|
818246 |
|
Oct 1951 |
|
DE |
|
624618 |
|
Sep 1978 |
|
SU |
|
Primary Examiner: Truluck; Dalton L.
Attorney, Agent or Firm: Weins; Michael J. Weins; Janine
J.
Claims
What I claim is:
1. A multi-lumen epidural-spinal needle comprising:
a first lumen having a first axis;
a second lumen having a second axis; and
a tissue piercing point through which said first lumen and said
second lumen exit, forming respectively a first opening and a
second opening, said first axis and said second axis being
parallel, and said openings diverging near said point such that a
catheter exiting said first opening will be deflected along a path
nearly perpendicular to said needle while said second opening
essentially aligns with said second lumen.
2. The multi-lumen needle of claim 1 wherein said first lumen is
larger than said second lumen.
3. The multi-lumen needle of claim 2 further comprising a hub in
which said first lumen and second lumen terminate.
4. The multi-lumen needle of claim 3 wherein said lumen diverge in
said hub.
5. The multi-lumen needle of claim 4 wherein said hub has a first
passage communicating with said first lumen and a second passage
communicating with said second lumen, said first passage and said
second passage diverging at an angle not greater than 15 degrees;
and further comprising a flange attached to said hub communicating
with said first passage, said flange serving as a syringe adapter
and having an index mark.
6. The multi-lumen needle of claim 2 wherein said first lumen and
said second lumen are in an over under relationship and are
connected by welding.
7. The multi-lumen needle of claim 6 wherein each of said lumen are
between 14 and 32 gauge.
8. The multi-lumen needle of claim 7 further comprising flanges
attached to said hub.
9. The multi-lumen needle of claim 4 further comprising a stop
attached to said hub to limit the depth of insertion of the
multi-lumen needle thereby avoiding separation of the skin by said
diverging lumina.
10. The multi-lumen needle of claim 8 further comprising a color
coded polymeric hub assembly to identify the size and tip
configuration of the needle.
Description
FIELD OF INVENTION
The present invention is directed to a multi-lumen needle and in
particular to a dual-lumen epidural-spinal needle earlier described
in Disclosure Document No. 170,906 dated May 29, 1987.
BACKGROUND
Punctures of the spinal area are required in conjunction with a
variety of medical and surgical procedures. Frequently medication,
and in particular, epidural and spinal anesthesics must be
introduced through a needle or a catheter. It may be desirable to
both introduce medication in the vicinity of the puncture through a
spinal needle and to introduce medication through a catheter to a
location remote from the puncture in the epidural or spinal
spaces.
Using prior art techniques, multiple punctures would have to be
made for simultaneous introduction of an epidural catheter and a
spinal needle, or for the introduction of two epidural and/or
spinal catheters. Multiple spinal punctures have greater risk than
a single puncture because of the increased trauma from additional
punctures and because the time required to perform the procedure
must be extended.
The present invention is directed to a new and improved multi-lumen
needle, and in particular a new improved epidural-spinal needle.
The needle of the present invention allows for location and
cannulation of the epidural space, the introduction of a spinal
needle, the introduction of spinal or epidural catheters, or the
introduction of multiple catheters through a single puncture.
A number of prior art patents teach epidural needles, spinal
needles and methods of introducing epidural catheters.
U.S. Pat. No. 4,141,365 teaches an epidural needle which can be
used for introducing a lead electrode or catheter.
U.S. Pat. No. 4,518,383 teaches a co-axial needle in which both
lumina are concentric and share a common axis. The needle of the
'383 patent has a tapered end and is provided with a stylet to
reduce coring. The needle of the '383 patent can be used for either
administering epidural or spinal anesthesia, but can not be used
for the administration of such simultaneously.
U.S. Pat. No. 4,349,023 teaches details of an adapter which can be
applied to an epidural needle to assist in the introduction of a
catheter.
Spinal anesthesia frequently requires the initial administration of
small quantities of an anesthetic agent into the subarachnoid
space. Since spinal anesthesia may be effective for only short
periods of time, an adjunctive epidural anesthetic technique that
can be continuous may be required for longer surgical procedures.
Alternatively, either continuous epidural or spinal techniques must
be utilized. The epidural technique yields a less dense local
anesthetic block, while the spinal technique can lead to equally
undesirable consequences including post spinal headache.
Significant advantages could be obtained if the epidural and spinal
procedures could be combined.
A procedure using conventional prior art single lumen needles to
administer the spinal and epidural anesthetic requires the
procedures either be performed at separate sites, or the two
procedures be separated by a time interval. It would be
advantageous and would reduce trauma if both procedures could be
carried out nearly simultaneously at the same site utilizing small
gauge spinal needles. If both procedures were carried out
simultaneously utilizing one puncture the length of the procedure,
and the discomfort to the patient would be reduced.
One option for using a single needle is to use a Touhy needle to
locate the epidural space and then to insert a spinal needle
through the Touhy needle to such an extent that the spinal needle
penetrates the dura. An anesthetic agent can then be administered
through the spinal needle. The spinal needle can then be withdrawn,
leaving the Touhy needle in position for use in introduction of an
epidural catheter in the usual way. This technique may have a
significant risk in that the epidural catheter will pass into the
subarachnoid space through the dural perforation and be undetected.
Also the immediate epidural catheterization is not assured.
If a single needle is not used for the administration of the spinal
and epidural anesthetic, but rather multiple needles are used,
multiple punctures must be made in separate locations. One puncture
is used for the insertion of, and to guide the spinal needle while
the other puncture is used for the introduction of a catheter or
for the introduction of a second needle.
If combined spinal and epidural anesthesia is to be used, the time
to complete the epidural cannulation must be minimized once the
spinal anesthetic is injected since a dangerous situation may occur
such as serious drops in blood pressure and/or pulse rate once the
spinal anesthetic has been administered. This dangerous situation
may arise during performance of the epidural catheterization since
using prior art techniques epidural catheterization must be
performed subsequent to the spinal anesthetic injection unless
multiple needles and multiple punctures are used.
The present invention is directed to a needle which will allow for
the simultaneous introduction of one or more needles, a needle and
a catheter, or multiple catheters through a single skin puncture.
Thus the present invention has advantages with respect to the prior
art by reducing trauma, reducing procedure time, and providing the
practitioner with a greater flexibility regarding the positioning
of the catheters and needles for a specific procedure since the
needle of the present invention can function as an introducer.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide a needle which
can be used to simultaneously perform spinal and epidural
cannulation and/or catheterization.
It is another object of the present invention to provide a needle
which can be used to simultaneously administer epidural medication
such as an anesthetic and be used to insert an epidural
catheter.
It is an object of the invention to provide a needle through which
it is possible to simultaneously administer medication to two
separate areas such as the lumbar epidural space and lumbar
intrathecal space.
It is an object of the invention to provide a needle through which
it is possible to simultaneously administer medication to two
separate areas without intermixing the medications.
It is another object of the present invention to provide a needle
which can be used to simultaneously administer medication while a
catheter is placed in either the epidural or the intrathecal
space.
It is another object of the invention to provide a needle which
allows two medicines to be administered without intermixing.
It is yet another objective of the present invention to provide a
needle which allows medication to be transported by separate
passages and/or catheters into separate regions of the body.
It is an object of the present invention to provide a needle
through which a spinal tap and spinal anesthetic/analgesic can be
initiated at any time after the epidural space has been
identified.
It is an object of the present invention to provide a needle
through which either a preliminary epidural injection, or placement
of an epidural catheter can be performed before or after a spinal
tap is initiated.
It is an object of the present invention to reduce the risk of
undetected cardiovascular hypotension during initiation of combined
epidural and spinal anesthesia.
It is an object of the present invention to reduce the number of
skin and/or spinal punctures for a given procedure.
It is an object of the present invention to reduce the incidence of
spinal headache by facilitating the introduction and use of smaller
spinal needles having a gauge size equal to or less than 26
gauge.
These and other objects of the present invention will become
apparent from the following figures and description.
The present invention is directed to a multi-lumen needle and in a
preferred embodiment to a dual-lumen epidural-spinal needle.
The needle of the present invention in its simplest form has two
lumina. The lumina terminate in a point and in a hub. The axes of
the lumina are parallel except near the hub where the lumina
diverge so as to provide easier access to each of the lumen
passages, and optionally near the point where the axes may diverge
so as to direct a catheter along a path nearly perpendicular to the
needle insertion path.
Preferably the hub allows for the attachment of one or more
conventional syringes.
Preferably the termination of the lumina in the hub is such that a
spinal needle and/or a catheter can be passed into and through each
of the lumen.
Preferably the hub is provided with a flange which can be readily
grasped and used to guide and position the needle.
In another preferred embodiment the hub flange is provided with
extensions which allow the needle to be readily grasped, positioned
and inserted.
Preferably the needle of the present invention is provided with
stylets to reduce coring during insertion.
In a preferred embodiment of the present invention the point of the
needle is so contoured that the needle can be rotated 360.degree.
with a minimum of coring and dragging of material.
Preferably the lumina have different cross sectional areas. The
smaller lower lumen can be used as an introducer for a spinal
needle used to perform a spinal tap. Thus the smaller of the
lumina, or spinal lumen is preferably of sufficient size to allow
for insertion of a spinal needle or microcatheter.
Preferably the larger lumen terminates at the hub in an attachment
or an adapter for a syringe, while the termination of the smaller
lumen is provided with a protuberance. The protuberance should be
contoured so as to be readily felt and to serve as a locator and
guide for the insertion of a spinal needle even in the event that
the entrance to the smaller lumen cannot be visually observed and
thus the spinal needle cannot be visually aligned for
insertion.
In another preferred embodiment of the present invention the lumina
terminate in a hub which is color coded in such a manner that
needles having different sizes and/or different point
configurations can be readily distinguished.
In yet another preferred embodiment of the present invention the
needle is encased in a polymeric material selected to facilitate
easy insertion and positioning of the needle.
Preferably the larger lumen, or epidural lumen is no larger than
required for insertion of a catheter. The larger lumen, or epidural
portion of the multi-lumen needle should have a gauge size less
than 14 gauge and preferably between approximately 16 and 20 gauge
and preferably about 18 gauge.
The needle of the present invention allows for the administration
of both epidural and spinal anesthesia almost simultaneously. The
simultaneous administration of epidural and spinal anesthesia
reduces the risk of undetected hypotension associated with the
administering of a spinal anesthesia prior to, or during, epidural
catheterization.
The needle of the present invention can serve as an introducer for
very small spinal needles of 26 to 32 gauge. The small spinal
needle can in turn be used for a spinal puncture or microcatheters
can be inserted intrathecally through the small gauge spinal
needle.
Preferably the lumen of the present invention terminate in a
Hustead point. Optionally the epidural and spinal needles are
rotated 180.degree. with respect to their axes so that two Hustead
points combine to form a wedge point. The wedge point aids in the
insertion, positioning and repositioning of the needle.
BRIEF DESCRIPTION OF THE FIGURES
FIG. 1 is a schematic representation of one embodiment of the
present invention in which a stylet is positioned in the larger, or
epidural lumen and a spinal needle is positioned in the smaller, or
spinal lumen. A portion of the needle hub has been cut away to show
details of the path taken by the spinal needle and stylet. The
entire needle assembly is encased in a smooth polymeric
material.
FIG. 2 is a schematic representation of another embodiment of the
present invention. A portion of the hub and the lumina has been cut
away to show details of the hub structure and the proximity of the
lumen passages. The walls of the lumina are maintained in intimate
contact by welding.
FIG. 3 is a schematic representation of an embodiment of the
present invention in which the wedge points of a spinal and an
epidural needle have been rotated with respect to each other by 180
degrees and positioned so as to provide a centrally disposed chisel
point. The hub of this particular embodiment is provided with two
different lumen entrance configurations. The epidural hub entrance
is provided with a flange so that a syringe can be attached. The
hub configuration at the entrance to the spinal lumen is provided
with a hub extension such that the entrance can be readily detected
by feel even if view is blocked by a syringe attached to the
epidural hub entrance. Stylets have been positioned in both lumina
to limit coring during insertion.
FIG. 4 is a schematic representation of the needle of the present
invention positioned in the spinal region. A catheter has been
placed through the epidural lumen and is positioned in the epidural
space. A spinal needle passed through the spinal lumen has
penetrated the dura.
FIG. 5 is a schematic representation of the embodiment of the
needle of the present invention shown in FIG. 3 positioned in the
spinal region. Two catheters have been passed through the lumina
and are positioned in the epidural space. Catheterization of the
epidural space both above and below the position at which the
needle was inserted is shown.
BEST MODE FOR CARRYING THE INVENTION INTO PRACTICE
FIG. 1 is a schematic representation of one embodiment of the
epidural-spinal needle of the present invention. The needle 10 has
a first lumen 12 and a second lumen 14. The lumina are positioned
in an over under relationship and terminate in a point 16 and a hub
18.
Preferably the lumina are of different size with the larger, or
epidural lumen 12 being of sufficient size to accommodate an
epidural catheter, and the smaller or spinal lumen 14 being of
sufficient size to permit passage of a spinal needle.
The walls of the lumina are bonded and terminate in a point 16. The
point preferably has the configuration of a standard or modified
Touhy or Hustead tip.
The nominal cross section of the needle 10 is oval or elliptical,
while the preferred cross section of each of the lumina is
circular. Preferably each of the lumina is between 14 and 32 gauge.
More preferably the needle 10 should have a maximum cross-sectional
dimension equal to, or less than, the diameter of a 14 gauge needle
with the larger epidural lumen 12 between about 16 to 20 gauge and
the smaller spinal lumen 14 between about 20 and 24 gauge.
The point 16 preferably has a modified Touhy configuration so that
a catheter which may be passed through the lumina will be directed
away from the lumina axes.
A stylet 20 is positioned in the epidural lumina 12. The stylet 20
avoids coring of body tissue and fluids during insertion of the
needle 10.
A spinal needle 22 is positioned in the second lumen 14. The spinal
needle 22 allows penetration into the tissue beyond the point
16.
The needle 10 is encased in a hard smooth plastic or polymeric
sheath 24. The sheath 24 provides a smooth continuous exterior
surface and can serve as to maintain the proximate relationship of
the needle components, the epidural lumen 12, the spinal lumen 14
and the hub 18. Optionally a partial plastic sleeve could be
provided to cover the lumina.
A syringe adapter 26 for attachment of a syringe is provided to the
hub 18 at the termination of the upper epidural lumen 12. The hub
18 is provided with an enlarged opening 28 in the vicinity of the
termination of the spinal lumen 14. The enlarged spinal lumen
opening 28 allows the spinal needle 22 to be easily inserted and
directed.
Preferably the syringe adapter 26 is provided with index marks
which allow the stylet 20 to be positioned so that the tip of the
needle 16 presents a smooth surface. A smooth tip 16 minimizes
coring during insertion of the needle 10.
Preferably flanges 30 are provided to the hub 18. The flanges 30
allow the needle to be grasped and positioned.
Preferably the lumen passages diverge at the hub 18 as is shown in
FIGS. 2 and 3. This divergence allows for easier insertion of
devices into the lumina.
FIG. 2 is a representation of a second embodiment of the
epidural-spinal needle 40 of the present invention. The walls of
the epidural lumen 42 and the spinal lumen 44 are connected by
means of welded seams 46. Preferably the welds form a continuous
smooth seam.
The lumina terminate in a hub 48. The hub 48 is provided with a
first passage 50 which mates with the first lumen 42 and a second
passage 52 which mates with the second lumen 44. The first passage
50 and the second passage 52 diverge so as to separate the
entrances to the lumina.
Communicating with the first passage 50 and extending away from the
hub 48 is a syringe adapter 54. The syringe adapter 54 allows a
conventional syringe, not shown, to be attached. The syringe
communicates with the epidural lumen 42 through the passage 50.
The syringe adapter 54 is provided with an indexing mark 56. The
indexing mark 56 can be used to indicate the position of the tip 58
and to position a stylet so that the stylet forms a smooth tip
surface so that coring will not occur during insertion of the
needle 40.
The size of the epidural lumen 42 is such that it can accommodate
the desired flow from a syringe, or alternatively an epidural
catheter can be inserted into and through the lumen and directed
into the epidural space.
The size of the spinal lumen 44 is such that a spinal needle 60 can
be passed through the second lumen 44.
The hub 48 can be made of a metal or polymeric material.
FIG. 3 shows an epidural spinal needle of the present invention in
which two stylets are positioned in the lumina. In this embodiment
the needle 60 has a first lumen 62 and a second lumen 64. The
lumina terminate in a point 66 which is formed by the merger of two
Hustead points so as to form a wedge configuration. Electron beam
welding or laser welding can be utilized to bond the walls of the
lumina.
The epidural-spinal needle 60 is provided with a hub 68. The hub 68
forces the lumina to diverge. The lumina should diverge to provide
a sufficient separation that easy access can be gained to either
lumen. The divergence is preferably approximately 15 degrees and
occurs over approximately one fourth of the length of the needle.
If the divergence is greater than 15 degrees it will be difficult
to advance a spinal needle in the spinal lumen 64. The divergent
end of the first lumen 62 and the second lumen 64 are affixed to
the hub 68. A proturbence 70 is provided to the hub 68 and
contoured so as to be readily felt and thus to serve as a locator
and a guide for insertion of a spinal needle even in the event that
the entrance to the smaller lumen cannot be visually observed and
thus the spinal needle cannot be visually aligned for
insertion.
A hub 68 encloses the divergent portion of the first lumen 62 and
the second lumen 64. Indexing information and information relating
to the size of the lumina and the particular point configurations
can be encoded on the hub 68. When a polymeric hub is used such
information can be included by color coding the polymer.
FIG. 4 is a schematic illustration of the epidural-spinal needle 80
of the present invention positioned for use. The epidural-spinal
needle 80 passes through the skin 82 and into the spinal column 84.
Preferably the two lumina are welded in such a way that between
them is a continuous and smooth seam. A catheter 88 is shown
inserted in the epidural space 90. The tip of the larger or
epidural lumen is positioned so that the termination or exit of the
lumen would direct a catheter cephalad into the epidural space. In
this mode it is possible to administer anesthesia through the
catheter 88 and to extract spinal fluids or administer spinal
anesthetics through the spinal needle 92. The catheter 88 is shown
inserted through the epidural lumen 86 cephalad into the epidural
space 90. A spinal needle 92 is passed through the spinal lumen 94
and exits penetrating the dura 96. A spinal catheter could be
passed intrathecally at this point through the introducing spinal
needle.
FIG. 5 shows the needle of FIG. 3 inserted in the spinal column
108. The needle 110 is positioned such that the needle tip 112 is
in the epidural space 114. Stop 116 on the hub 118 on the needle
110 limits the depth of penetration of the needle tip 112 and avoid
separation of skin by the diverging lumina.
When the needle is positioned, an upper catheter 120 can be
inserted into the upper lumen 122 to be positioned so as to provide
medication to a site above the needle tip 112. A lower catheter 124
can be inserted in the lower lumen 126 and positioned so as to
provide medication to a site below the needle tip 112, yet still in
the epidural space 114.
The Multi-Purpose Epidural-Spinal Needle has particular utility for
the administration of spinal and/or epidural anesthesia. Using the
needle of the present invention anesthesia may be provided
independently, concurrently or sequentially to the spinal and/or
the epidural regions.
The needle of the present invention when inserted may also be used
as a spinal needle guide or introducer to sample the cerebro spinal
fluid contained in the subarachnoid space while the needle is
simultaneously used to insert catheters into the epidural and/or
intrathecal spaces.
The interior surface of the lumina should be smooth to facilitate
the ready insertion of a needle and catheters.
Using the epidural-spinal needle of the present invention
conventional technology such as the loss of resistance method can
be used to locate the epidural space.
The Multi-Purpose Epidural-Spinal Needle of the present invention
is contoured in such a manner that the distal end or tip bends
shortly before the termination of the needle at a 90 degree angle
to the tracking path of the epidural needle. By bending the
direction of the lumen in this manner, the epidural-spinal needle
after insertion is so contoured as to facilitate the introduction
and cephalad direction of an epidural catheter upward and parallel
to the spinal cord. Alternatively the assembly can be introduced
upside down, and the epidural catheter may be directed downward or
caudally in the epidural space.
The needle of the present invention is particularly well suited for
providing spinal medication or catheter insertion into the
subarachnoid CSF space. The needle of the present invention can
also be used for purposes other than spinal taps and administering
medication to the spinal area. The needle of the present invention
provides two lumina which are effectively two passages into and/or
out of the body through one insertion and such passages are so
contoured as to be directed away from each other. Once within the
body, such a needle could have application in a number of branches
of medicine.
While the present invention has been described in terms of
preferred embodiments and particular applications, substitution in
detail and design by one skilled in the art can be made without
departing from the spirit of the invention.
* * * * *